Formulation / Product Development
From concept to finished product, our formulation scientists help manufacturers, entrepreneurs, and established companies create new products or improve existing ones. Our formulation scientists have years of experience working with a diversity of matrices. Unlike other contract facilities, Chemir clients retain the full rights to the final product. We help consult with many of our clients’ outside vendors (Packagers, Suppliers, Manufacturers) along the way to deliver the finished product meeting their expectations.
Concept Development
Beginning with a concept, the experts at Chemir Analytical Services can develop ideas into products. We begin by asking the customer to identify the desired characteristics of their new product, discussing aesthetics, types of fragrance, marketing claims, packaging, and full production needs.
We can provide useful preliminary research using our extensive library, as well as consulting chemical supplier formularies, colleagues and the internet. Our formulation experts have vast experience in a wide variety of non-OTC (cosmetics), OTC, and household products including:
• Liquids
• Pastes
• Lotions/creams
• Gels
• Powders
• And more...
During this time packaging also plays a key role in the product development. Initial packaging ideas play an integral roll in the formulation standards of each product, i.e., appearance, color, odor, pH, viscosity, solids, and specific gravity. Chemir works with its clients to find packagers that are suitable for each project.
Formulation
After ingredients are determined, our scientists write the initial formulation and production procedures. Initially, small batches are formulated in the lab to determine the right balance of ingredients. Typically this is done at the gram scale, resulting in the first bench-scale batch. After making adjustments to match the customer's concept, the bench-scale formula is finalized.
At this point, any equipment issues for large scale production are addressed. Product specifications are derived, and the product is prepared for stability testing. If a preservative system is needed, it will be tested for efficacy, and any active ingredients will be assayed. Additional safety testing is also suggested to see if the product reacts in a positive or negative manner with different skin conditions.
Stability
If a product is meant for the home, health and beauty market, a stability profile is needed to ensure the product remains safe and effective over a long period of time. A standard stability test is run over a 90 day period. During this time, the product undergoes various stability testing in its final packaging which includes:
• Room temperature
• Freeze-thaw
• 40°C oven
In addition, UV light exposure testing is included for products that are known to break down after light exposure, as well as packaging systems in clear bottles.
Preservative Efficacy and Safety Testing
PET or Preservative Efficacy Testing is a 4-6 week study used to challenge the preservative system used in the formulation of the product. During the study, bacterium is swabbed onto Petri Dishes of the product and culture over the time period. If no growth appears on the product over the duration of the study, the product is then given approval to be released in the marketplace.
RIPT or Human Repeat Insult Patch Testing is a 4-6 week study developed to check for skin irritation. During the study, the product is applied onto small patches and then placed on a volunteers’ skin. Over time the test volunteers will have the patch checked for irritation to the skin. Information from this study is generally used to determine potential warnings and claim substantiation.
Scale-Up
Production at the scale-up phase results in further adjustments to the product formulation. Following the initial bench top formulation a 5 gallon bench scale-up batch is produced and tested against its original specifications. Revisions will be made until it meets the correct product specifications. Next a 55 gallon batch is produced, followed by a 500 gallon production scale batch. Due to Chemir’s capabilities, scale-up larger than 5 gallons will be transferred to a contract manufacturer/packager. Unfortunately, large scale-up versions of the process rarely imitate the small scale production. Careful modifications are made throughout the process to insure the final scaled-up version represents the initial lab scale. Methods for quality control are also developed along the way to insure the product meets its standard.
Consultation
Chemir Analytical Services provides assurance that your product will be developed according to the highest standards. We can help find raw materials, including chemicals, packaging and manufacturing equipment. Our home, health and beauty experts can also help select a contract manufacturer and be your agent in supervising or training production of your product.
Case Study
Dr. Anne Riordan of Wildwood Dermatology came to Chemir with a concept of a product that would fill a need for their patients. The product was a facial skin care gel with unique capabilities and ingredients. Chemir discussed their objectives and vision for the final product, legal aspects (patents) and the manufacturing process.
Dr. Anne Riordan knew several skin care formulations that she preferred, but wanted the product to be in a gel form and include natural ingredients for additional moisturizing properties. Chemir’s formulation scientist created three iterations of the formulation for her review. The formula was tweaked to obtain the desired texture, odor and color. Once the personal care formulation was finalized and approved, the lab created bench-scale quantities for 12 week stability tests. After the stability studies were complete, Chemir partnered with a recommended contract packager. With the help of all these partners, a new product, Azfasst, was born.
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